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Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae

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ClinicalTrials.gov Identifier: NCT00723268
Recruitment Status : Unknown
Verified July 2008 by Mashhad University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : July 28, 2008
Last Update Posted : July 29, 2008
Sponsor:
Collaborator:
University of Tehran
Information provided by:
Mashhad University of Medical Sciences

Brief Summary:
The purpose of this study is to determine whether low doses of prednisolone, or colchicine are effective in the treatment of oral aphthae.

Condition or disease Intervention/treatment Phase
Oral Aphthae Drug: Prednisolone Drug: Colchicine Phase 2

Detailed Description:
Treatment of recurrent aphthous stomatitis (RAS) remains, to date, empirical and non-specific. The main goals of therapy are to minimize pain and functional disabilities as well as decrease inflammatory reactions and frequency of recurrences.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae
Study Start Date : May 2007
Estimated Primary Completion Date : August 2008


Arm Intervention/treatment
Active Comparator: Prednisolone Drug: Prednisolone
5MG Prednisolone per day for 3 months
Active Comparator: Colchicine Drug: Colchicine
0.5 MG Colchicine per day for 3 months



Primary Outcome Measures :
  1. frequency of ulcers [ Time Frame: 1 year ]


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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Confirmation of clinical diagnosis of aphthae
  • Having the experience of oral aphthae at least once in a month
  • Two weeks wash out periods after the last treatment

Exclusion Criteria:

  • History of any systemic disease
  • Using drugs which affect immune system
  • Pregnancy and breast feeding
  • Aphthous related syndromes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723268


Locations
Iran, Islamic Republic of
Mashhad Dental school
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735
Sponsors and Collaborators
Mashhad University of Medical Sciences
University of Tehran

Responsible Party: Mashhad University of Medical Science, Mashhad Dental Research Center
ClinicalTrials.gov Identifier: NCT00723268     History of Changes
Other Study ID Numbers: 286293
286293
First Posted: July 28, 2008    Key Record Dates
Last Update Posted: July 29, 2008
Last Verified: July 2008

Keywords provided by Mashhad University of Medical Sciences:
Oral ulcers

Additional relevant MeSH terms:
Stomatitis, Aphthous
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Colchicine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators